Platinum-Free Systemic Therapy in First-Line Metastatic Urothelial Carcinoma: Mirage or Oasis in the Platinum Desert? Cancer predictive or diagnostic assays, offered as Laboratory-Developed Tests ...
After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.
A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...
Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...
Clinical Laboratory Improvement Amendments, or CLIA, are a high bar as set by the US Government under Clinical Laboratory Improvement Amendment 42 CFR 493.1253 to obtain and maintain quality ...
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